(399 days)
Not Found
No
The description focuses on signal detection and data logging, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device is intended to monitor and log ingestion events, not to treat or prevent a disease or condition.
No
The device is described as an "ingestible event marker" that logs, tracks, and trends intake times. It is intended for "quantifiable analysis of ingestion events" and for "unattended data collection for clinical applications." It is not described as providing diagnostic information or conclusions about a patient's health condition.
No
The device description explicitly states the system is comprised of the ID-Capsule (ingestible sensor) and the ID-Cap Reader (wearable device), in addition to the software. This indicates the system includes significant hardware components.
Based on the provided information, the ID-Cap System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ID-Cap System Function: The ID-Cap System's primary function is to log, track, and trend intake times of an ingestible sensor. It detects an event (ingestion) within the body and transmits that information externally. It does not analyze biological specimens taken from the body.
- Intended Use: The intended use is focused on monitoring ingestion events for clinical applications and research, not on analyzing biological samples for diagnostic purposes.
- Device Description: The description highlights an "in vivo communications technology" and detection of a signal "from within the patient." This is the opposite of an in vitro process.
Therefore, the ID-Cap System falls outside the scope of an In Vitro Diagnostic device. It is more accurately described as an ingestible event marker or a system for monitoring medication adherence or other ingestion-related events.
N/A
Intended Use / Indications for Use
The ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical and research applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events signaled by the co-incidence with or coingestion with the ID-Capsule, is desirable.
Product codes (comma separated list FDA assigned to the subject device)
OZW
Device Description
The ID-Cap System is an ingestible event marker. It utilizes an in vivo communications technology that emits a very low power radio frequency (RF) digital message from within the patient after a sensor is ingested and detects the signal using a wearable Reader.
The ID-Cap System is comprised of the ID-Capsule, the ID-Cap Reader, and related software which allows data to be displayed for the patient and clinician.
The ID-Capsule consists of a standard pharmaceutical capsule shell containing the ID-Tag (the ingestible sensor).
The ID-Cap Reader is a wearable device, which receives the message from the ID-Tag, verifies the message as being a valid ingestion event, and forwards the data using the Bluetooth Low Energy (BLE) protocol to data display systems utilized by clinicians and patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Clinical study participants were 18 – 79 years old (mean 41.9 years), stratified by gender and BMI.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing Summary - The clinical trials performed demonstrates that the ID-Cap System does not raise different questions of safety and effectiveness. These clinical trials included evaluations of the following parameters:
- Positive Detection Accuracy (PDA)
- Negative Detection Accuracy (NDA)
- Effect of gender and BMI on PDA
- Time to detection of ingestion
- Duration of detected signal
- Time to phone receipt and time to server receipt following ingestion of the ID-Capsule
- Adverse events
- Proper excretion of ID-Tags as evidenced by post-ingestion X-rays showing non-retention of ID-Tags
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Detection Accuracy (PDA): 95.0%
Negative Detection Accuracy (NDA): 100% (95% CI)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6305 Ingestible event marker.
(a)
Identification. An ingestible event marker is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible and non-toxic;
(2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper excretion of the device;
(3) Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance, and electrical safety; and
(4) Labeling must include a detailed summary of the nonclinical and clinical testing pertinent to use of the device and the maximum number of daily device ingestions.
0
December 6, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
etectRx, Inc. Paul Dryden Consultant 747 SW 2nd Ave Suite 365T, IMB 24 Gainesville, Florida 32601
Re: K183052
Trade/Device Name: ID-Cap System Regulation Number: 21 CFR 880.6305 Regulation Name: Ingestible Event Marker Regulatory Class: Class II Product Code: OZW Dated: November 26, 2019 Received: November 27, 2019
Dear Paul Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Jessica Paulsen Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
ID-Cap System
Indications for Use (Describe)
The ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events, including events signaled by the co-incidence with or co-ingestion with the ID-Capsule,
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
JOver-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
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| Official Contact: | Susan Baumgartner, PharmD, MBA
VP, Product Management & Regulatory Affairs
etectRx, Inc.
747 SW 2nd Ave Suite
365T, IMB 24
Gainesville, FL 32601
Tel – (352) 443-5713 x110 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | ID-Cap System |
| Common/Usual Name: | Ingestible event marker |
| Classification Name: | 21 CFR 880.6305
OZW – Ingestible event marker Class
II |
| Predicate Devices: | K150494 – Ingestion Event Marker (IEM) Data
recorder (Patch) |
Device Description
The ID-Cap System is an ingestible event marker. It utilizes an in vivo communications technology that emits a very low power radio frequency (RF) digital message from within the patient after a sensor is ingested and detects the signal using a wearable Reader.
The ID-Cap System is comprised of the ID-Capsule, the ID-Cap Reader, and related software which allows data to be displayed for the patient and clinician.
The ID-Capsule consists of a standard pharmaceutical capsule shell containing the ID-Tag (the ingestible sensor).
The ID-Cap Reader is a wearable device, which receives the message from the ID-Tag, verifies the message as being a valid ingestion event, and forwards the data using the Bluetooth Low Energy (BLE) protocol to data display systems utilized by clinicians and patients.
Indications for Use
The ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical and research applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events signaled by the co-incidence with or coingestion with the ID-Capsule, is desirable.
Comparison of ID-Cap System to Predicate
We present in Tables 1 - 5 a comparison of the subject device compared to the predicate.
4
Table 1 – Comparison - High-Level System
| | Predicate
K150494 | Subject Device | Comments |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Proteus Digital Health Feedback Device | ID-Cap System | Identical |
| Classification | Ingestible Event Marker
(21 CFR 880.6305) | Ingestible Event Marker
(21 CFR 880.6305) | |
| Product Code | OZW, DXH | OZW | Product code DXH is not relevant for
the subject device, since the subject
device does not include a telephone
electrocardiograph transmitter and
receiver. |
| System Components | Ingestion Event Marker (IEM)
Data recorder (Patch)
Software | ID-Capsule (with ID-Tag)
ID-Cap Reader
Software | Similar components. An ingestible
sensor, a wearable data recorder, and
software |
| Indications for Use | The Proteus Digital Health Feedback
Device consists of a miniaturized,
wearable sensor for ambulatory recording
of physiological and behavioral metrics
such as heart rate, activity, body angle
relative to gravity (body position), and
time-stamped patient logged events,
including events signaled by the co-
incidence with, or co-ingestion with, the
ingestible sensor accessory. When the
ingestible sensor is ingested, the Proteus
Digital Health Feedback Device is
intended to log, track and trend intake
times. When co-ingested with medication,
the tracking and trending of intake times
may be used as an aid to measure
medication adherence. The Proteus
Digital Health Feedback Device may be
used in any instance where quantifiable | The ID-Cap System consists of a
wearable reader for ambulatory
recording of events signaled by
swallowing the ID-Capsule which
contains the ID-Tag, an ingestible sensor.
The ID-Cap System is intended to log,
track, and trend intake times and enables
unattended data collection for clinical
applications. The ID-Cap System may be
used in any instance where quantifiable
analysis of ingestion events, including
events signaled by the co-incidence with
or co-ingestion with the ID-Capsule, is
desirable. | The indications for use of the subject
device are a subset of the indications
for use of the predicate. |
| | Predicate | Subject Device | Comments |
| | K150494 | | |
| | analysis of event-associated physiological
and behavioral metrics is desirable and
enables unattended data collection for
clinical and research applications. | | |
| Patient Population | Based on current labeling, clinical study
volunteers were 21–85 years old (mean:
44.6 years). | Clinical study participants were 18 – 79
years old (mean 41.9 years), stratified by
gender and BMI. | Similar |
| Environment of Use | Ambulatory use
Unattended data collection for clinical
and research applications
Do not wear during airplane travel
Intended for use in specified
electromagnetic environment | Ambulatory use
Unattended data collection for clinical
and research applications
Not intended for use on aircraft
Intended for use in specified
electromagnetic environment | Identical
Neither is designed for use in aircraft |
| Prescription use | Yes | Yes | Identical |
5
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Table 2 – Comparison - Technological Characteristics – Ingestible Sensor
| | Predicate
K150494 | ID-Cap System | Comments |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Ingestion Event Marker | ID-Capsule (capsule containing the ID-
Tag, an ingestible sensor) | |
| Ingestible Sensor | Integrated circuit (IC) with attached 5
mm diameter x 300µm semi-rigid
insulating skirt disk (excipient skirt) | ID-Tag is a 22.5 mm x 9.5 mm x 60
microns (L x W x H) flexible substrate
with printed antenna, attached IC and
capacitor | Different physical characteristics of
ingestible sensor - Both are ICs
mounted on a small, thin substrate. |
| Basic Technology | Bio-galvanically powered ingestible
circuit | Bio-galvanically powered
ingestible circuit | Similar |
| Method of Signal
Communication | Volume conduction communication
High frequency AC (alternating
current) | Very low power digital radio frequency
(RF) messages | Different method of signal
communication, but fundamentally a
low-powered signal |
| Electrical Power Source | Differential metal contacts (Mg-CuCl)
activated by electrolytes in stomach
fluid
Mineral biogalvanic | Differential metal contacts (Mg-AgCl)
activated by electrolytes in stomach fluid
Mineral biogalvanic | Similar means of powering but using
different metal technology |
| Activation | When wet in stomach | When wet in stomach | Similar activation |
| Time to Detect | 1.0 minute (mean) in direct
observation clinical study | 6.4 minutes (mean) for ID-Tag
encapsulated in ID-Capsule in direct
observation clinical study | The capsule takes ~ 6 minutes to
dissolve vs. the predicate which is not
encapsulated; however, the duration of
detected signal is longer for the subject
device. |
| Duration of Detected Signal | 7.29 minutes (mean) in direct
observation clinical study | 27.9 minutes (mean) from first detection
in direct observation clinical study | Subject device has a longer duration of
detection |
| Signaling Control | 1 mm x 1 mm x 0.3 mm
complementary metal-oxide
semiconductor (CMOS) IC | 1 mm x 1 mm x 0.3 mm complementary
metal-oxide semiconductor (CMOS) IC | Similar |
| Oral Delivery Vehicle | Ingestible sensor is attached to an inert
pharmaceutical excipient tablet | Ingestible sensor is encapsulated in a
standard pharmaceutical capsule shell | Similar – Oral delivery vehicles for
both are inert and listed in the FDA
inactive ingredient database |
| | Predicate
K150494 | ID-Cap System | Comments |
| Swallowable Size and
Weight | Round pill
Size: 6.5 mm x 2.0 mm
Weight: 80 mg | Capsule
Size and weight below for size 00 gelatin
capsule
Size:
Locked length = 23.5 mm
Cap diameter = 8.56 mm
Body diameter = 8.21 mm
Weight: 24.3 mg | The subject device is delivered in a
standard pharmaceutical capsule shell,
while the predicate is a tablet
configuration. |
| Patient-Contacting
Material | Tested per ISO 10993-1 | Tested per ISO 10993-1 | Testing per ISO 10993, and all patient-
contacting materials found
biocompatible |
| Data Transmitted from the
Sensor | Digital signaling information,
including unique ID for the ingestible
sensor | Digital signaling information consisting of
RF signals with encoded digital data | Similar data transmitted. See row
below for unique ID discussion. |
| Unique ID for Sensor | Each sensor is encoded with a unique
ID which is recorded by the patch. | The ID-Tag sends RF messages to the
Reader which assigns a unique ingestion
event ID number to the ID-Tag messages
received. | Unique ID is generated within the
Reader vs. pre-assigned to the
ingestible sensor.
Simultaneous ingestions of multiple
ID-Capsules are not recommended with
the subject device. |
| Excretion | Chip excreted via GI tract | ID-Tag excreted via GI tract | Similar
Safety demonstrated in clinical studies
with post-ingestion X-ray confirmation
of non-retention of ID-Tags. |
| Maximum Number of
Ingestions per Day | Do not exceed more than 30 ingestions
per day. | No more than five ingestions per day, with
a minimum of 90 minutes between ID-
Capsule ingestions to ensure that each ID-
Tag is appropriately identified and each
ingestion event is detected. | Single ingestions with a minimum of
90 minutes between ingestions for the
subject device. |
| | Predicate
K150494 | ID-Cap System | Comments |
| Common name | Proteus Personal Monitor (Patch) | ID-Cap Reader | |
| Data Recorder Description | Adhesive patch worn on the skin | Pendant hanging from a lanyard worn
around the neck | The subject device Reader is not
attached to the patient's skin. |
| Function | Receives, stores, and wirelessly sends
ingestion confirmation data to a
general computing device | Receives, stores, and wirelessly sends
ingestion confirmation data to a general
computing device | Similar |
| Form Factor | Body-worn sensor attached to the skin
with an adhesive patch | Pendant hanging in front of the chest
from a lanyard placed loosely around the
neck | Similar, except predicate is an
adhesive patch placed on the patient's
skin |
| Memory and Data Storage | Stores data
Ovoid patch 4 MB or 16 MB;
Rectangular patch 16 MB | Stores data
8 MB | Similar
Storage capacity is adequate for the
intended use. |
| Size | One-Piece Ovoid Patch:
102 mm x 60 mm x 9.8 mm or
102 mm x 60 mm x 6.3 mm
Two-Piece Rectangular Patch:
98 mm x 42 mm x 11 mm | 97 mm x 47 mm x 23 mm | Similar - Both are small and wearable.
The subject device can be easily taken
off between ingestions. |
| Weight | Ovoid Patch 10 g or 11 g
Rectangular Patch 16 g | 78 g | |
| Battery Type | Lithium Manganese (LiMn) Coin Cell | Rechargeable Lithium Polymer | Similar - The subject device is a
rechargeable unit, whereas the
predicate is a one-time use, disposable
unit. |
| Battery Life | Data recording for 5-7 days | Rechargeable battery designed to last at
least 36 hours on a full charge;
Qi-compliant wireless charger included
with Reader | Similar – Battery life is adequate for
intended use. |
| Data Reception | Wireless, skin contact required | Wireless, skin contact not required | Subject device does not require skin
contact. |
| | Predicate
K150494 | ID-Cap System | Comments |
| Data Recorded | Time-stamped, patient-logged events,
including events signaled by
swallowing the Ingestion Event
Marker (IEM) accessory
Records digital ID and date and time
of ingestion confirmation
Records heart rate, activity, body angle
relative to gravity (body position),
temperature, heart rate variability,
respiratory rate, and inter-electrode
impedance | Time-stamped, patient-logged events,
including events signaled by swallowing
the ID-Capsule
Records assigned ingestion event ID
number and date and time of ingestion
confirmation
No physiological metrics collected
Records Reader status and channel
communication information | The ingestion event marking is similar.
The subject device does not capture
physiological metrics. |
| Device Monitoring | Inter-electrode impedance helps
determine proper wearing of patch for
detection | Reader messages communicate device
status.
Accelerometer (motion detection)
provides insight into patient use of
Reader and whether user is wearing it. | The subject device Reader is less
position and placement dependent than
the predicate device. |
| Manual Event Logging | Manually press an event marker button
on the Patch
Sensor technology: patient-activated
button
Method: digital pulse | Not on the ID-Cap Reader, but available
in the ID-Cap App | The subject device does not have a
manual event logging feature itself;
however, the ID-Cap App does. |
| Data Communication | Wirelessly sends data to a general
computing device via Bluetooth | Wirelessly sends data to a general
computing device via Bluetooth Low
Energy (BLE) protocol | Similar methods |
| User Interface | Patch button initiates communication
to mobile computing device
Manual event marker button
Indicator light | Single on/off/standby button - once
turned on, device is ready for use
Tri-color LED indicator light | Similar - Simple user interface |
| Reusable Components /
Disposal | Single-use only | Reusable | The subject device Reader is reusable. |
| | Predicate
K150494 | ID-Cap System | Comments |
| Biocompatibility and Toxicity Testing | | | |
| Biocompatibility and
Toxicity -Data Recorder
(Reader) | Patch is attached to the patient's skin
Tested and demonstrated to be
biocompatible and non-toxic | Reader has no direct attachment to the
patient
Tested and demonstrated to be
biocompatible and non-toxic | ISO 10993 testing performed includes:
cytotoxicity, sensitization, and
irritation testing. |
| Biocompatibility and
Toxicity - Ingestible Sensor | Ingestible sensor demonstrated to be
biocompatible and non-toxic | Ingestible sensor demonstrated to be
biocompatible and non-toxic | ISO 10993 testing performed includes:
cytotoxicity, sensitization, irritation,
pyrogenicity, implantation, acute
systemic toxicity, and subacute
systemic toxicity. |
| Additional biocompatibility
testing | Chemical characterization with risk-
based toxicity assessment | Chemical characterization with risk-
based toxicity assessment | Testing and assessment performed |
| Electrical Safety, EMC, and Battery Testing | | | |
| Electrical Safety | IEC 60601-1 | IEC 60601-1:2005 (3rd Edition) IEC
60601-1-11:2015 | Tested to applicable standards and
passed |
| Electromagnetic
Compatibility | IEC 60601-1-2 | IEC 60601-1-2:2014 (4th Edition and
home use levels)
JIS T 0601-1-2 (12th Edition 2012) | Tested to applicable standards and
passed |
| Wireless Coexistence
Performance | Tested | ANSI C63.27 2017 Wireless
Coexistence | Testing performed and acceptable |
| Spectrum Compatibility
and RF Safety | N/A | FCC and Industry Canada Grant of
Authorization received - relevant
Rules Parts and Radio Systems
Specifications | Testing performed and acceptable |
| Mechanical and Electrical Performance | | | |
| Impact Resistance | Passed | IEC 60601-1:2005 (3rd Edition) IEC
60601-1-11:2015 | Testing performed and results
acceptable |
| Performance of Antenna
Used in IEM | Mechanical strength
Residual solvent of disc material
Friability
Electrical properties of disc | Mechanical strength
N/A
N/A
Electrical properties | Applicable testing performed and
results acceptable |
| | Predicate
K150494 | ID-Cap System | Comments |
| Non-Clinical Performance
Testing of Ingestible Sensor | Tested for activation time and lifetime
after activation | Tested for activation time and lifetime
after activation | Applicable testing performed and
results acceptable |
| Signal Reception
Performance of Data
Recorder | High frequency (HF) and low
frequency (LF) signal chain
performance tests | Reader bench testing | Applicable testing performed and
results acceptable |
| System Performance
Testing | Device performance for event marking
in simulated bench testing and clinical
testing | Device performance for event marking
in simulated bench testing and clinical
testing | Similar |
| Proper Excretion of Device | Animal testing | Post-ingestion X-rays in clinical
studies | Human testing performed with
X-ray confirmation of non-retention
for the subject device. |
| Shelf-Life | Testing referenced in labeling | Shelf-life testing performed for ID-
Capsules, and shelf-life/aging analysis
performed for Readers. | Applicable testing performed and
results acceptable |
| Human Factors and Usability Evaluation | | | |
| Human Factors/Usability | Testing performed | Testing performed with two user
groups: patient users and clinician
users | Human factors/usability testing
performed and results acceptable |
7
8
Table 3 – Comparison - Technological Characteristics – Data Recorder
9
10
Table 4 – Comparison of Performance Testing
11
12
| | Predicate
K150494 | ID-Cap System | Comments |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Studies of Safety and Performance – Key Measures | | | |
| Positive Detection
Accuracy (PDA) | 97.2% (95% CI)
cumulative average | 95.0% | Similar PDA |
| Negative Detection
Accuracy (NDA) | 100% (95% CI)
cumulative average | 100% (95% CI) | Similar NDA |
| Maximum daily
ingestions in clinical
studies | 34 IEMs | 5 ID-Capsules | Subject device is not
designed for multiple
ingestible sensor
ingestions simultaneously;
therefore, fewer total daily
ingestions are possible. |
| Unanticipated adverse
device effects | None | None | Similar |
| Severe adverse events
related to or possibly
related to the System | None | None | Similar |
| Discontinuations due
to AEs | 2.8% of subjects
discontinued due to skin
irritation | None | Subject device does not
have direct skin contact;
thus, this risk is mitigated. |
| Ingestible sensor AEs | 5.7% of subjects
(overall non-serious AEs
- 92% mild and 8%
moderate in severity)
0% of ingestions | 10.2% of subjects
(100% mild in severity)
in pooled safety
analysis
Incidence of at least one
related AE is 0.6% of
ingestions | Similar with respect to
incidence and severity of
adverse events reported
with use of the device in
clinical studies. |
| Data recorder AEs | 17.7% of subjects
reported localized skin
irritation and
inflammation with patch | None | Subject device design
mitigates this risk. |
Table 5 - Comparison of Clinical Performance
Discussion of the Comparison and Differences
As presented in Tables 2 - 5, we have compared the etectRx ID-Cap System ("ID-Cap System") to the predicate, Proteus Digital Health Feedback Device ("Proteus" cleared under K150494) for equivalence of:
Indications, Patient Population and Environment of Use – The ID-Cap System is seeking similar indications for use as a device which is intended to log, track, and trend intake times and enables unattended data collection for clinical and research applications. It may be used in any instance where quantifiable analysis of ingestion events, including events signaled by the co-incidence with or co-ingestion with the ingestible sensor, is desirable.
The patient population and environment of use are similar.
Discussion – The indications for use of the subject device are a subset of the indications for use of the predicate. These differences do not raise new or different risk concerns than the predicate; thus, they are substantially equivalent.
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Prescription-Use Only - Both devices are prescription-use only.
Discussion - There is no difference in the type of device as a prescription device; thus, they are substantially equivalent.
Design, Technology and Principle of Operation – The fundamental design, technology, and principle of operation of a bio-galvanically powered ingestible circuit that, when activated by stomach fluid, sends a wireless signal to a data recorder is similar between the subject device and predicate.
The subject device generates a unique ID for the ingestion event when the Reader detects the first signal from the ingested sensor, whereas the predicate sensor is pre-assigned a unique ID that is then transmitted to the data recorder (i.e., patch).
Discussion - The subject ID-Capsule which encapsulates the ID-Tag is a standard pharmaceutical capsule shell which dissolves, allowing the ID-Tag to be activated. The time to activation is longer than the predicate as the capsule must first dissolve, but the time available to detect the output signal from the ID-Tag is significantly longer.
The subject device Reader receives the RF signal with no requirement for direct skin contact, while the predicate requires the data recorder (i.e., patch) to be attached to a specific location over the stomach and adhere properly to the patient's skin in order to receive the signal via conduction.
The information transmitted for the subject device relates only to the ingestion event and Reader status. The subject device does not collect, send, or track physiological metrics like the predicate.
The difference of how the unique ID is provided still results in each ingestion event being recorded and tracked under a unique ID.
These differences do not raise different risk concerns than the predicate; thus, they are substantially equivalent.
Performance -
Non-Clinical Testing Summary -
Biocompatibility - In following the Special Controls, ISO 10993-1 testing was performed as appropriate for the respective patient-contacting materials in the ingestible sensor and the data recorder.
Discussion - The test results demonstrated that the patient-contacting materials were biocompatible.
Bench Testing
The subject device has been tested for performance and compliance as it relates to electrical safety, EMC, wireless coexistence, shelf-life, mechanical performance, ingestible sensor performance, Reader detection performance, and system performance to ensure that all requirements have been met.
Discussion - The subject device met its performance requirements. Any differences did not raise new or different concerns about safety or effectiveness, and, thus, the subject device can be considered substantially equivalent to the predicate.
Human Factors/Usability - As required under the Special Controls, we performed Human Factors / Usability testing. We identified the applicable user groups and conducted a summative usability validation study. The results supported the design, function, appropriate use, and performance of the subject device for the intended use population.
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Clinical Testing Summary -
The clinical trials performed demonstrates that the ID-Cap System does not raise different questions of safety and effectiveness. These clinical trials included evaluations of the following parameters:
- Positive Detection Accuracy (PDA) ●
- . Negative Detection Accuracy (NDA)
- . Effect of gender and BMI on PDA
- Time to detection of ingestion ●
- Duration of detected signal
- . Time to phone receipt and time to server receipt following ingestion of the ID-Capsule
- Adverse events ●
- Proper excretion of ID-Tags as evidenced by post-ingestion X-rays showing non-retention of ID-Tags ●
Substantial Equivalence Conclusion
The ID-Cap System is substantially equivalent to the predicate in: indications for use, patient population, environment of use, technology characteristics, specifications / performance, and clinical evaluations.
The differences, as detailed above, do not raise different risks of safety and effectiveness. Thus, the subject device can be considered substantially equivalent to the predicate device.